Transcatheter Aortic Valve Implantation (TAVI): Bringing a Medical Device to Market (pp. 699-714)
Authors: (Thomas A. Vassiliades and John Liddicoat)
Abstract: Valve repair/replacement and coronary artery bypass grafting are the most common cardiac surgical procedures performed today. Historically, aortic valve replacement has required open heart surgery, disqualifying many patients for whom the risks of such surgery are too great. Partly for this reason, the surgical heart valve market is in decline as more patients requiring valve replacement fall into a high-risk category.
Recent advances in transcatheter aortic valve implantation (TAVI), however, have brought the benefits of aortic valve replacement to those higher risk patients. The TAVI procedure is performed with fluoroscopic and echocardiographic guidance by an interdisciplinary team that includes cardiac surgeons, cardiologists, and anesthesiologists. Typically, it is performed in a setting where both catheter-based and surgical facilities can be immediately accessed.
How does a device such as TAVI make its way from ―promising idea‖ into the surgical repertoire? This chapter provides an overview of the risks, challenges, and opportunities inherent in bringing a device to market together with a perspective on the subject from Medtronic, a leader in the field of structural heart disease.